The following data is part of a premarket notification filed by Microline Surgical, Inc with the FDA for Microline Flexible Ligating Shears.
| Device ID | K124029 |
| 510k Number | K124029 |
| Device Name: | MICROLINE FLEXIBLE LIGATING SHEARS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MICROLINE SURGICAL, INC 800 CUMMING CENTER SUITE 166T Beverly, MA 01915 |
| Contact | Dean Ciporkin |
| Correspondent | Dean Ciporkin MICROLINE SURGICAL, INC 800 CUMMING CENTER SUITE 166T Beverly, MA 01915 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-03-27 |
| Summary: | summary |